Integrated System for Intravascular Placement of a Catheter

ABSTRACT

An integrated catheter placement system for accurately placing a catheter within a patient&#39;s vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient&#39;s chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to intravascular introduction of the catheter. The ultrasound probe includes user input controls for controlling use of the ultrasound probe in an ultrasound mode and use of the tip location sensor in a tip location mode. In another embodiment, ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient&#39;s heart.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/323,273, which claims the benefit of the following U.S. ProvisionalPatent Applications: Application No. 60/990,242, filed Nov. 26, 2007,and titled “Integrated Ultrasound and Tip Location System forIntravascular Placement of a Catheter;” Application No. 61/095,921,filed Sep. 10, 2008, and titled “System and Method for Placing aCatheter Within a Vasculature of a Patient;” Application No. 61/091,233,filed Aug. 22, 2008, and titled “Catheter Including Preloaded SteerableStylet;” Application No. 61/095,451, filed Sep. 9, 2008, and titled“Catheter Assembly Including ECG and Magnetic-Based Sensor Stylet;” andApplication No. 61/045,944, filed Apr. 17, 2008, and titled“Drape-Breaching Electrical Connector,” each of which is incorporatedherein by reference in its entirety.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toan integrated catheter placement system configured for accuratelyplacing a catheter within the vasculature of a patient. The integratedsystem employs at least two modalities for improving catheter placementaccuracy: 1) ultrasound-assisted guidance for introducing the catheterinto the patient's vasculature; and 2) a tip location system (“TLS”), ormagnetically-based (e.g., via permanent magnet(s) or electromagnet(s))tracking of the catheter tip during its advancement through thevasculature to detect and facilitate correction of any tip malpositionduring such advancement.

In one embodiment, the integrated system comprises a system consoleincluding a control processor, a tip location sensor for temporaryplacement on a portion of a body of the patient, and an ultrasoundprobe. The tip location sensor senses a magnetic field of a styletdisposed in a lumen of the catheter when the catheter is disposed in thevasculature. The ultrasound probe ultrasonically images a portion of thevasculature prior to introduction of the catheter into the vasculature.In addition, the ultrasound probe includes user input controls forcontrolling use of the ultrasound probe in an ultrasound mode and use ofthe tip location sensor in a tip location mode.

In another embodiment, a third modality, i.e., ECG signal-based cathetertip guidance, is included in the system to enable guidance of thecatheter tip to a desired position with respect to a node of thepatient's heart from which the ECG signals originate.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a block diagram depicting various elements of an integratedsystem for intravascular placement of a catheter, according to oneexample embodiment of the present invention;

FIG. 2 is a simplified view of a patient and a catheter being insertedtherein with assistance of the integrated system of FIG. 1;

FIGS. 3A and 3B are views of a probe of the integrated system of FIG. 1;

FIG. 4 is a screenshot of an ultrasound image as depicted on a displayof the integrated system of FIG. 1;

FIG. 5 is a perspective view of a stylet employed in connection with thesystem of FIG. 1 in placing a catheter within a patient vasculature;

FIG. 6 is an icon as depicted on a display of the integrated system ofFIG. 1, indicating a position of a distal end of the stylet of FIG. 5during catheter tip placement procedures;

FIGS. 7A-7E depict various example icons that can be depicted on thedisplay of the integrated system of FIG. 1 during catheter tip placementprocedures;

FIGS. 8A-8C are screenshots of images depicted on a display of theintegrated system of FIG. 1 during catheter tip placement procedures;

FIG. 9 is a block diagram depicting various elements of an integratedsystem for intravascular placement of a catheter, according to anotherexample embodiment of the present invention;

FIG. 10 is a simplified view of a patient and a catheter being insertedtherein with assistance of the integrated system of FIG. 9;

FIG. 11 is a perspective view of a stylet employed in connection withthe integrated system of FIG. 9 in placing a catheter within a patientvasculature;

FIGS. 12A-12E are various views of portions of the stylet of FIG. 11;

FIGS. 13A-13D are various views of a fin connector assembly for use withthe integrated system of FIG. 9;

FIGS. 14A-14C are views showing the connection of a stylet tether andfin connector to a sensor of the integrated system of FIG. 9;

FIG. 15 is a cross sectional view of the connection of the stylettether, fin connector, and sensor shown in FIG. 14C;

FIG. 16 is simplified view of an ECG trace of a patient; and

FIG. 17 is a screenshot of an image depicted on a display of theintegrated system of FIG. 9 during catheter tip placement procedures.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

FIGS. 1-17 depict various features of embodiments of the presentinvention, which is generally directed to a catheter placement systemconfigured for accurately placing a catheter within the vasculature of apatient. In one embodiment, the catheter placement system employs atleast two modalities for improving catheter placement accuracy: 1)ultrasound-assisted guidance for introducing the catheter into thepatient's vasculature; and 2) a tip location/navigation system (“TLS”),or magnetically-based tracking of the catheter tip during itsadvancement through the tortuous vasculature path to detect andfacilitate correction of any tip malposition during such advancement.The ultrasound guidance and tip location features of the present systemaccording to one embodiment are integrated into a single device for useby a clinician placing the catheter. Integration of these two modalitiesinto a single device simplifies the catheter placement process andresults in relatively faster catheter placements. For instance, theintegrated catheter placement system enables ultrasound and TLSactivities to be viewed from a single display of the integrated system.Also, controls located on an ultrasound probe of the integrated device,which probe is maintained within the sterile field of the patient duringcatheter placement, can be used to control functionality of the system,thus precluding the need for a clinician to reach out of the sterilefield in order to control the system.

In another embodiment, a third modality, i.e., ECG signal-based cathetertip guidance, is included in the integrated system to enable guidance ofthe catheter tip to a desired position with respect to a node of thepatient's heart from which the ECG signals originate. Such ECG-basedpositional assistance is also referred to herein as “tip confirmation.”

Combination of the three modalities above according to one embodimentenables the catheter placement system to facilitate catheter placementwithin the patient's vasculature with a relatively high level ofaccuracy, i.e., placement of the distal tip of the catheter in apredetermined and desired position. Moreover, because of the ECG-basedguidance of the catheter tip, correct tip placement may be confirmedwithout the need for a confirmatory X-ray. This, in turn, reduces thepatient's exposure to potentially harmful x-rays, the cost and timeinvolved in transporting the patient to and from the x-ray department,costly and inconvenient catheter repositioning procedures, etc.

Reference is first made to FIGS. 1 and 2 which depict various componentsof a catheter placement system (“system”), generally designated at 10,configured in accordance with one example embodiment of the presentinvention. As shown, the system 10 generally includes a console 20,display 30, probe 40, and sensor 50, each of which is described infurther detail below.

FIG. 2 shows the general relation of these components to a patient 70during a procedure to place a catheter 72 into the patient vasculaturethrough a skin insertion site 73. FIG. 2 shows that the catheter 72generally includes a proximal portion 74 that remains exterior to thepatient and a distal potion 76 that resides within the patientvasculature after placement is complete. The system 10 is employed toultimately position a distal tip 76A of the catheter 72 in a desiredposition within the patient vasculature. In one embodiment, the desiredposition for the catheter distal tip 76A is proximate the patient'sheart, such as in the lower one-third (⅓^(rd)) portion of the SuperiorVena Cava (“SVC”). Of course, the system 10 can be employed to place thecatheter distal tip in other locations. The catheter proximal portion 74further includes a hub 74A that provides fluid communication between theone or more lumens of the catheter 72 and one or more extension legs 74Bextending proximally from the hub.

An example implementation of the console 20 is shown in FIG. 8C, thoughit is appreciated that the console can take one of a variety of forms. Aprocessor 22, including non-volatile memory such as EEPROM for instance,is included in the console 20 for controlling system function duringoperation of the system 10, thus acting as a control processor. Adigital controller/analog interface 24 is also included with the console20 and is in communication with both the processor 22 and other systemcomponents to govern interfacing between the probe 40, sensor 50, andother system components.

The system 10 further includes ports 52 for connection with the sensor50 and optional components 54 including a printer, storage media,keyboard, etc. The ports in one embodiment are USB ports, though otherport types or a combination of port types can be used for this and theother interfaces connections described herein. A power connection 56 isincluded with the console 20 to enable operable connection to anexternal power supply 58. An internal battery 60 can also be employed,either with or exclusive of an external power supply. Power managementcircuitry 59 is included with the digital controller/analog interface 24of the console to regulate power use and distribution.

The display 30 in the present embodiment is integrated into the console20 and is used to display information to the clinician during thecatheter placement procedure. In another embodiment, the display may beseparate from the console. As will be seen, the content depicted by thedisplay 30 changes according to which mode the catheter placement systemis in: US, TLS, or in other embodiments, ECG tip confirmation. In oneembodiment, a console button interface 32 (see FIGS. 1, 8C) and buttonsincluded on the probe 40 can be used to immediately call up a desiredmode to the display 30 by the clinician to assist in the placementprocedure. In one embodiment, information from multiple modes, such asTLS and ECG, may be displayed simultaneously, such as in FIG. 17. Thus,the single display 30 of the system console 20 can be employed forultrasound guidance in accessing a patient's vasculature, TLS guidanceduring catheter advancement through the vasculature, and (as in laterembodiments) ECG-based confirmation of catheter distal tip placementwith respect to a node of the patient's heart. In one embodiment, thedisplay 30 is an LCD device.

FIGS. 3A and 3B depict features of the probe 40 according to oneembodiment. The probe 40 is employed in connection with the firstmodality mentioned above, i.e., ultrasound (“US”)-based visualization ofa vessel, such as a vein, in preparation for insertion of the catheter72 into the vasculature. Such visualization gives real time ultrasoundguidance for introducing the catheter into the vasculature of thepatient and assists in reducing complications typically associated withsuch introduction, including inadvertent arterial puncture, hematoma,pneumothorax, etc.

The handheld probe 40 includes a head 80 that houses a piezoelectricarray for producing ultrasonic pulses and for receiving echoes thereofafter reflection by the patient's body when the head is placed againstthe patient's skin proximate the prospective insertion site 73 (FIG. 2).The probe 40 further includes a plurality of control buttons 84, whichcan be included on a button pad 82. In the present embodiment, themodality of the system 10 can be controlled by the control buttons 84,thus eliminating the need for the clinician to reach out of the sterilefield, which is established about the patient insertion site prior tocatheter placement, to change modes via use of the console buttoninterface 32.

As such, in one embodiment a clinician employs the first (US) modalityto determine a suitable insertion site and establish vascular access,such as with a needle or introducer, then with the catheter. Theclinician can then seamlessly switch, via button pushes on the probebutton pad 82, to the second (TLS) modality without having to reach outof the sterile field. The TLS mode can then be used to assist inadvancement of the catheter 72 through the vasculature toward anintended destination.

FIG. 1 shows that the probe 40 further includes button and memorycontroller 42 for governing button and probe operation. The button andmemory controller 42 can include non-volatile memory, such as EEPROM, inone embodiment. The button and memory controller 42 is in operablecommunication with a probe interface 44 of the console 20, whichincludes a piezo input/output component 44A for interfacing with theprobe piezoelectric array and a button and memory input/output component44B for interfacing with the button and memory controller 42.

FIG. 4 shows an example screenshot 88 as depicted on the display 30while the system 10 is in its first ultrasound modality. An image 90 ofa subcutaneous region of the patient 70 is shown, depicting a crosssection of a vein 92. The image 90 is produced by operation of thepiezoelectric array of the probe 40. also included on the displayscreenshot 88 is a depth scale indicator 94, providing informationregarding the depth of the image 90 below the patient's skin, a lumensize scale 96 that provides information as to the size of the vein 92relative to standard catheter lumen sizes, and other indicia 98 thatprovide information regarding status of the system 10 or possibleactions to be taken, e.g., freeze frame, image templates, data save,image print, power status, image brightness, etc.

Note that while a vein is depicted in the image 90, other body lumens orportions can be imaged in other embodiments. Note that the US mode shownin FIG. 4 can be simultaneously depicted on the display 30 with othermodes, such as the TLS mode, if desired. In addition to the visualdisplay 30, aural information, such as beeps, tones, etc., can also beemployed by the system 10 to assist the clinician during catheterplacement. Moreover, the buttons included on the probe 40 and theconsole button interface 32 can be configured in a variety of ways,including the use of user input controls in addition to buttons, such asslide switches, toggle switches, electronic or touch-sensitive pads,etc. Additionally, both US and TLS activities can occur simultaneouslyor exclusively during use of the system 10.

As just described, the handheld ultrasound probe 40 is employed as partof the integrated catheter placement system 10 to enable USvisualization of the peripheral vasculature of a patient in preparationfor transcutaneous introduction of the catheter. In the present exampleembodiment, however, the probe is also employed to control functionalityof the TLS portion, or second modality, of the system 10 when navigatingthe catheter toward its desired destination within the vasculature asdescribed below. Again, as the probe 40 is used within the sterile fieldof the patient, this feature enables TLS functionality to be controlledentirely from within the sterile field. Thus the probe 40 is adual-purpose device, enabling convenient control of both US and TLSfunctionality of the system 10 from the sterile field. In oneembodiment, the probe can also be employed to control some or allECG-related functionality, or third modality, of the catheter placementsystem 10, as described further below.

The catheter placement system 10 further includes the second modalitymentioned above, i.e., the magnetically-based catheter TLS, or tiplocation system. The TLS enables the clinician to quickly locate andconfirm the position and/or orientation of the catheter 72, such as aperipherally-inserted central catheter (“PICC”), central venous catheter(“CVC”), or other suitable catheter, during initial placement into andadvancement through the vasculature of the patient 70. Specifically, theTLS modality detects a magnetic field generated by a magneticelement-equipped tip location stylet, which is pre-loaded in oneembodiment into a longitudinally defined lumen of the catheter 72, thusenabling the clinician to ascertain the general location and orientationof the catheter tip within the patient body. In one embodiment, themagnetic assembly can be tracked using the teachings of one or more ofthe following U.S. Pat. Nos. 5,775,322; 5,879,297; 6,129,668; 6,216,028;and 6,263,230. The contents of the afore-mentioned U.S. patents areincorporated herein by reference in their entireties. The TLS alsodisplays the direction in which the catheter tip is pointing, thusfurther assisting accurate catheter placement. The TLS further assiststhe clinician in determining when a malposition of the catheter tip hasoccurred, such as in the case where the tip has deviated from a desiredvenous path into another vein.

As mentioned, the TLS utilizes a stylet to enable the distal end of thecatheter 72 to be tracked during its advancement through thevasculature. FIG. 5 gives an example of such a stylet 100, whichincludes a proximal end 100A and a distal end 100B. A handle is includedat the stylet proximal end 100A, with a core wire 104 extending distallytherefrom. A magnetic assembly is disposed distally of the core wire104. The magnetic assembly includes one or more magnetic elements 106disposed adjacent one another proximate the stylet distal end 100B andencapsulated by tubing 108. In the present embodiment, a plurality ofmagnetic elements 106 is included, each element including a solid,cylindrically shaped ferromagnetic stacked end-to-end with the othermagnetic elements. An adhesive tip 110 can fill the distal tip of thetubing 108, distally to the magnetic elements 106.

Note that in other embodiments, the magnetic elements may vary from thedesign in not only shape, but also composition, number, size, magnetictype, and position in the stylet distal segment. For example, in oneembodiment, the plurality of ferromagnetic magnetic elements is replacedwith an electromagnetic assembly, such as an electromagnetic coil, whichproduces a magnetic field for detection by the sensor. Another exampleof an assembly usable here can be found in U.S. Pat. No. 5,099,845entitled “Medical Instrument Location Means,” which is incorporatedherein by reference in its entirety. Yet other examples of styletsincluding magnetic elements that can be employed with the TLS modalitycan be found in U.S. application Ser. No. 11/466,602, filed Aug. 23,2006, and entitled “Stylet Apparatuses and Methods of Manufacture,”which is incorporated herein by reference in its entirety. These andother variations are therefore contemplated by embodiments of thepresent invention. It should appreciated herein that “stylet” as usedherein can include any one of a variety of devices configured forremovable placement within a lumen of the catheter to assist in placinga distal end of the catheter in a desired location within the patient'svasculature.

FIG. 2 shows disposal of the stylet 100 substantially within a lumen inthe catheter 72 such that the proximal portion thereof extendsproximally from the catheter lumen, through the hub 74A and out througha selected one of the extension legs 74B. So disposed within a lumen ofthe catheter, the distal end 100B of the stylet 100 is substantiallyco-terminal with the distal catheter end 76A such that detection by theTLS of the stylet distal end correspondingly indicates the location ofthe catheter distal end.

The TLS sensor 50 is employed by the system 10 during TLS operation todetect a magnetic field produced by the magnetic elements 106 of thestylet 100. As seen in FIG. 2, the TLS sensor 50 is placed on the chestof the patient during catheter insertion. The TLS sensor 50 is placed onthe chest of the patient in a predetermined location, such as throughthe use of external body landmarks, to enable the magnetic field of thestylet magnetic elements 106, disposed in the catheter 72 as describedabove, to be detected during catheter transit through the patientvasculature. Again, as the magnetic elements 106 of the stylet magneticassembly are co-terminal with the distal end 76A of the catheter 72(FIG. 2), detection by the TLS sensor 50 of the magnetic field of themagnetic elements provides information to the clinician as to theposition and orientation of the catheter distal end during its transit.

In greater detail, the TLS sensor 50 is operably connected to theconsole 20 of the system 10 via one or more of the ports 52, as shown inFIG. 1. Note that other connection schemes between the TLS sensor andthe system console can also be used without limitation. As justdescribed, the magnetic elements 106 are employed in the stylet 100 toenable the position of the catheter distal end 76A (FIG. 2) to beobservable relative to the TLS sensor 50 placed on the patient's chest.Detection by the TLS sensor 50 of the stylet magnetic elements 106 isgraphically displayed on the display 30 of the console 20 during TLSmode. In this way, a clinician placing the catheter is able to generallydetermine the location of the catheter distal end 76A within the patientvasculature relative o the TLS sensor 50 and detect when cathetermalposition, such as advancement of the catheter along an undesiredvein, is occurring.

FIGS. 6 and 7A-7E show examples of icons that can be used by the consoledisplay 30 to depict detection of the stylet magnetic elements 106 bythe TLS sensor 50. In particular, FIG. 6 shows an icon 114 that depictsthe distal portion of the stylet 100, including the magnetic elements106 as detected by the TLS sensor 50 when the magnetic elements arepositioned under the TLS sensor. As the stylet distal end 100B issubstantially co-terminal with the distal end 76A of the catheter 72,the icon indicates the position and orientation of the catheter distalend. FIGS. 7A-7E show various icons that can be depicted on the on theconsole display 30 when the magnetic elements 106 of the stylet 100 arenot positioned directly under a portion of the TLS sensor 50, but arenonetheless detected nearby. The icons can include half-icons 114A andquarter-icons 114B that are displayed according to the position of thestylet magnetic assembly, i.e., the magnetic elements 106 in the presentembodiment, relative to the TLS sensor 50.

FIGS. 8A-8C depict screenshots taken from the display 30 of the system10 while in TLS mode, showing how the magnetic assembly of the stylet100 is depicted. The screenshot 118 of FIG. 8A shows a representativeimage 120 of the TLS sensor 50. Other information is provided on thedisplay screenshot 118, including a depth scale indicator 124,status/action indicia 126, and icons 128 corresponding to the buttoninterface 32 included on the console 20 (FIG. 8C). Though the icons 128in the present embodiment are simply indicators to guide the user inidentifying the purpose of the corresponding buttons of the buttoninterface 32, in another embodiment the display can be madetouch-sensitive so that the icons themselves can function as buttoninterfaces and can change according to the mode the system is in.

During initial stages of catheter advancement through the patient'svasculature after insertion therein, the distal end 76A of the catheter72, having the stylet distal end 100B substantially co-terminaltherewith, is relatively distant from the TLS sensor 50. As such, thedisplay screenshot will indicate “no signal,” indicating that themagnetic field from the stylet magnetic assembly has not been detected.In FIG. 8B, the magnetic assembly proximate the stylet distal end 100Bhas advanced sufficiently close to the TLS sensor 50 to be detectedthereby, though it is not yet under the sensor. This is indicated by thehalf-icon 114A shown to the left of the sensor image 120, representingthe stylet magnetic assembly being positioned to the right of the TLSsensor 50 from the perspective of the patient.

In FIG. 8C, the magnetic assembly proximate the stylet distal end 100Bhas advanced under the TLS sensor 50 such that its position andorientation relative thereto is detected by the TLS sensor. This isindicated by the icon 114 on the sensor image 120. Note that the buttonicons 128 provide indications of the actions that can be performed bypressing the corresponding buttons of the console button interface 32.As such, the button icons 128 can change according to which modality thesystem 10 is in, thus providing flexibility of use for the buttoninterface 32. Note further that, as the button pad 82 of the probe 40(FIG. 3A, 3B) includes buttons 84 that mimic several of the buttons ofthe button interface 32, the button icons 128 on the display 30 providea guide to the clinician for controlling the system 10 with the probebuttons 84 while remaining in the sterile field. For instance, if theclinician has need to leave TLS mode and return to US (ultrasound) mode,the appropriate control button 84 on the probe button pad 82 can bedepressed, and the US mode can be immediately called up, with thedisplay 30 refreshing to accommodate the visual information needed forUS functionality, such as that shown in FIG. 4. This is accomplishedwithout a need for the clinician to reach out of the sterile field.

Reference is now made to FIGS. 9 and 10 in describing the integratedcatheter placement system 10 according to another example embodiment. Asbefore, the integrated system 10 includes the console 20, display 30,probe 40 for US functionality, and the TLS sensor 50 for tip locationfunctionality as described above. Note that the system 10 depicted inFIGS. 9 and 10 is similar in many respects to the system shown in FIGS.1 and 2. As such, only selected differences will be discussed below. Thesystem 10 of FIGS. 9 and 10 includes additional functionality whereindetermination of the proximity of the catheter distal tip 76A relativeto a sino-atrial (“SA”) or other electrical impulse-emitting node of theheart of the patient 70 can be determined, thus providing enhancedability to accurately place the catheter distal tip in a desiredlocation proximate the node. Also referred to herein as “ECG” or“ECG-based tip confirmation,” this third modality of the system 10enables detection of ECG signals from the SA node in order to place thecatheter distal tip in a desired location within the patientvasculature. Note that the US, TLS, and ECG modalities are seamlesslycombined in the present system 10 and can be employed in concert orindividually to assist in catheter placement.

FIGS. 9 and 10 show the addition to the system 10 of a stylet 130configured in accordance with the present embodiment. As an overview,the catheter stylet 130 is removably predisposed within the lumen of thecatheter 72 being inserted into the patient 70 via the insertion site73. The stylet 130, in addition to including a magnetic assembly for themagnetically-based TLS modality, includes an ECG sensor assemblyproximate its distal end and including a portion that is co-terminalwith the distal end of the catheter tip for sensing ECG signals producedby the SA node. In contrast to the previous embodiment, the stylet 130includes a tether 134 extending from its proximal end that operablyconnects to the TLS sensor 50. As will be described in further detail,the stylet tether 134 permits ECG signals detected by the ECG sensorassembly included on a distal portion of the stylet 130 to be conveyedto the TLS sensor 50 during confirmation of the catheter tip location aspart of the ECG signal-based tip confirmation modality. Reference andground ECG lead/electrode pairs 158 attach to the body of the body ofthe patient 70 and are operably attached to the TLS sensor 50 to enablethe system to filter out high level electrical activity unrelated to theelectrical activity of the SA node of the heart, thus enabling theECG-based tip confirmation functionality. Together with the referenceand ground signals received from the ECG lead/electrode pairs 158 placedon the patient's skin, the ECG signals sensed by the stylet ECG sensorassembly are received by the TLS sensor 50 positioned on the patient'schest (FIG. 10). The TLS sensor 50 and/or console processor 22 canprocess the ECG signal data to produce an electrocardiogram waveform onthe display 30, as will be described. In the case where the TLS sensor50 processes the ECG signal data, a processor is included therein toperform the intended functionality. If the console 20 processes the ECGsignal data, the processor 22, controller 24, or other processor can beutilized in the console to process the data.

Thus, as it is advanced through the patient vasculature, the catheter 72equipped with the stylet 130 as described above can advance under theTLS sensor 50, which is positioned on the chest of the patient as shownin FIG. 10. This enables the TLS sensor 50 to detect the position of themagnetic assembly of the stylet 130, which is substantially co-terminalwith the distal tip 76A of the catheter as located within the patient'svasculature. The detection by the TLS sensor 50 of the stylet magneticassembly is depicted on the display 30 during ECG mode. The display 30further depicts during ECG mode an ECG electrocardiogram waveformproduced as a result of patient heart's electrical activity as detectedby the ECG sensor assembly of the stylet 130. In greater detail, the ECGelectrical activity of the SA node, including the P-wave of thewaveform, is detected by the ECG sensor assembly of the stylet(described below) and forwarded to the TLS sensor 50 and console 20. TheECG electrical activity is then processed for depiction on the display30. clinician placing the catheter can then observe the ECG data todetermine optimum placement of the distal tip 76A of the catheter 72,such as proximate the SA node in one embodiment. In one embodiment, theconsole 20 which includes the electronic components, such as theprocessor 22 (FIG. 9) necessary to receive and process the signalsdetected by the stylet ECG sensor assembly. In another embodiment, theTLS sensor 50 can include the necessary electronic components processingthe ECG signals.

As already discussed, the display 30 is used to display information tothe clinician during the catheter placement procedure. The content ofthe display 30 changes according to which mode the catheter placementsystem is in: US, TLS, or ECG. Any of the three modes can be immediatelycalled up to the display 30 by the clinician, and in some casesinformation from multiple modes, such as TLS and ECG, may be displayedsimultaneously. In one embodiment, as before, the mode the system is inmay be controlled by the control buttons 84 included on the handheldprobe 40, thus eliminating the need for the clinician to reach out ofthe sterile field (such as touching the button interface 32 of theconsole 20) to change modes. Thus, in the present embodiment the probe40 is employed to also control some or all ECG-related functionality ofthe system 10. Note that the button interface 32 or other inputconfigurations can also be used to control system functionality. Also,in addition to the visual display 30, aural information, such as beeps,tones, etc., can also be employed by the system to assist the clinicianduring catheter placement.

Reference is now made to FIGS. 11-12E in describing various details ofone embodiment of the stylet 130 that is removably loaded into thecatheter 72 and employed during insertion to position the distal tip 76Aof the catheter in a desired location within the patient vasculature. Asshown, the stylet 130 as removed from the catheter defines a proximalend 130A and a distal end 130B. A connector 132 is included at theproximal stylet end 130A, and a tether 134 extends distally from theconnector and attaches to a handle 136. A core wire 138 extends distallyfrom the handle 136. The stylet 130 is pre-loaded within a lumen of thecatheter 72 in one embodiment such that the distal end 130B issubstantially flush, or co-terminal, with the catheter opening at thedistal end 76A thereof (FIG. 10), and such that a proximal portion ofthe core wire 138, the handle 136, and the tether 134 extend proximallyfrom a selected one of the extension tubes 74B. Note that, thoughdescribed herein as a stylet, in other embodiments a guidewire or othercatheter guiding apparatus could include the principles of theembodiment described herein.

The core wire 138 defines an elongate shape and is composed of asuitable stylet material including stainless steel or a memory materialsuch as, in one embodiment, a nickel and titanium-containing alloycommonly known by the acronym “nitinol.” Though not shown here,manufacture of the core wire 138 from nitinol in one embodiment enablesthe portion of the core wire corresponding to a distal segment of thestylet to have a pre-shaped bent configuration so as to urge the distalportion of the catheter 72 into a similar bent configuration. In otherembodiments, the core wire includes no pre-shaping. Further, the nitinolconstruction lends torqueability to the core wire 138 to enable a distalsegment of the stylet 130 to be manipulated while disposed within thelumen of the catheter 72, which in turn enables the distal portion ofthe catheter to be navigated through the vasculature during catheterinsertion.

The handle 136 is provided to enable insertion/removal of the styletfrom the catheter 72. In embodiments where the stylet core wire 138 istorqueable, the handle 136 further enables the core wire to be rotatedwithin the lumen of the catheter 72, to assist in navigating thecatheter distal portion through the vasculature of the patient 70.

The handle 136 attaches to a distal end of the tether 134. In thepresent embodiment, the tether 134 is a flexible, shielded cable housingone or more conductive wires electrically connected both to the corewire 138, which acts as the ECG sensor assembly referred to above, andthe tether connector 132. As such, the tether 134 provides a conductivepathway from the distal portion of the core wire 138 through to thetether connector 132 at proximal end 130A of the stylet 130. As will beexplained, the tether connector 132 is configured for operableconnection to the TLS sensor 50 on the patient's chest for assisting innavigation of the catheter distal tip 76A to a desired location withinthe patient vasculature.

As seen in FIGS. 12B-12D, a distal portion of the core wire 138 isgradually tapered, or reduced in diameter, distally from a junctionpoint 142. A sleeve 140 is slid over the reduced-diameter core wireportion. Though of relatively greater diameter here, the sleeve inanother embodiment can be sized to substantially match the diameter ofthe proximal portion of the stylet core wire. The stylet 130 furtherincludes a magnetic assembly disposed proximate the distal end 130Bthereof for use during TLS mode. The magnetic assembly in theillustrated embodiment includes a plurality of magnetic elements 144interposed between an outer surface of the reduced-diameter core wire138 and an inner surface of the sleeve 140 proximate the stylet distalend 130B. In the present embodiment, the magnetic elements 144 include20 ferromagnetic magnets of a solid cylindrical shape stacked end-to-endin a manner similar to the stylet 100 of FIG. 2. In other embodiments,however, the magnetic element(s) may vary from this design in not onlyshape, but also composition, number, size, magnetic type, and positionin the stylet. For example, in one embodiment the plurality of magnetsof the magnetic assembly is replaced with an electromagnetic coil thatproduces a magnetic field for detection by the TLS sensor. These andother variations are therefore contemplated by embodiments of thepresent invention.

The magnetic elements 144 are employed in the stylet 130 distal portionto enable the position of the stylet distal end 130B to be observablerelative to the TLS sensor 50 placed on the patient's chest. As has beenmentioned, the TLS sensor 50 is configured to detect the magnetic fieldof the magnetic elements 144 as the stylet advances with the catheter 72through the patient vasculature. In this way, a clinician placing thecatheter 72 is able to generally determine the location of the catheterdistal end 76A within the patient vasculature and detect when cathetermalposition is occurring, such as advancement of the catheter along anundesired vein, for instance.

The stylet 130 further includes the afore-mentioned ECG sensor assembly,according to one embodiment. The ECG sensor assembly enables the stylet130, disposed in a lumen of the catheter 72 during insertion, to beemployed in detecting an intra-atrial ECG signal produced by an SA orother node of the patient's heart, thereby allowing for navigation ofthe distal tip 76A of the catheter 72 to a predetermined location withinthe vasculature proximate the patient's heart. Thus, the ECG sensorassembly serves as an aide in confirming proper placement of thecatheter distal tip 76A.

In the embodiment illustrated in FIGS. 11-12E, the ECG sensor assemblyincludes a distal portion of the core wire 138 disposed proximate thestylet distal end 130B. The core wire 138, being electricallyconductive, enables ECG signals to be detected by the distal end thereofand transmitted proximally along the core wire. A conductive material146, such as a conductive epoxy, fills a distal portion of the sleeve140 adjacent the distal termination of the core wire 138 so as to be inconductive communication with the distal end of the core wire. This inturn increases the conductive surface of the distal end 130B of thestylet 130 so as to improve its ability to detect ECG signals.

Before catheter placement, the stylet 130 is loaded into a lumen of thecatheter 72. Note that the stylet 130 can come preloaded in the catheterlumen from the manufacturer, or loaded into the catheter by theclinician prior to catheter insertion. The stylet 130 is disposed withinthe catheter lumen such that the distal end 130B of the stylet 130 issubstantially co-terminal with the distal tip 76A of the catheter 72,thus placing the distal tips of both the stylet and the catheter insubstantial alignment with one another. The co-terminality of thecatheter 72 and stylet 130 enables the magnetic assembly to functionwith the TLS sensor 50 in TLS mode to track the position of the catheterdistal tip 76A as it advances within the patient vasculature, as hasbeen described. Note, however, that for the tip confirmationfunctionality of the system 10, the distal end 130B of the stylet 130need not be co-terminal with the catheter distal end 76A. Rather, allthat is required is that a conductive path between the vasculature andthe ECG sensor assembly, in this case the core wire 138, be establishedsuch that electrical impulses of the SA node or other node of thepatient's heart can be detected. This conductive path in one embodimentcan include various components including saline solution, blood, etc.

In one embodiment, once the catheter 72 has been introduced into thepatient vasculature via the insertion site 73 (FIG. 10) the TLS mode ofthe system 10 can be employed as already described to advance thecatheter distal tip 76A toward its intended destination proximate the SAnode. Upon approaching the region of the heart, the system 10 can beswitched to ECG mode to enable ECG signals emitted by the SA node to bedetected. As the stylet-loaded catheter is advanced toward the patient'sheart, the electrically conductive ECG sensor assembly, including thedistal end of the core wire 138 and the conductive material 146, beginsto detect the electrical impulses produced by the SA node. As such, theECG sensor assembly serves as an electrode for detecting the ECGsignals. The elongate core wire 138 proximal to the core wire distal endserves as a conductive pathway to convey the electrical impulsesproduced by the SA node and received by the ECG sensor assembly to thetether 134.

The tether 134 conveys the ECG signals to the TLS sensor 50 temporarilyplaced on the patient's chest. The tether 134 is operably connected tothe TLS sensor 50 via the tether connector 132 or other suitable director indirect connective configuration. As described, the ECG signal canthen be process and depicted on the system display 30 (FIG. 9, 10).Monitoring of the ECG signal received by the TLS sensor 50 and displayedby the display 30 enables a clinician to observe and analyze changes inthe signal as the catheter distal tip 76A advances toward the SA node.When the received ECG signal matches a desired profile, the cliniciancan determine that the catheter distal tip 76A has reached a desiredposition with respect to the SA node. As mentioned, in one embodimentthis desired position lies within the lower one-third (⅓rd) portion ofthe SVC.

The ECG sensor assembly and magnetic assembly can work in concert inassisting a clinician in placing a catheter within the vasculature.Generally, the magnetic assembly of the stylet 130 assists the clinicianin generally navigating the vasculature from initial catheter insertionso as to place the distal end 76A of the catheter 72 in the generalregion of the patient's heart. The ECG sensor assembly can then beemployed to guide the catheter distal end 76A to the desired locationwithin the SVC by enabling the clinician to observe changes in the ECGsignals produced by the heart as the stylet ECG sensor assemblyapproaches the SA node. Again, once a suitable ECG signal profile isobserved, the clinician can determine that the distal ends of both thestylet 130 and the catheter 72 have arrived at the desired location withrespect to the patient's heart. Once it has been positioned as desired,the catheter 72 may be secured in place and the stylet 130 removed fromthe catheter lumen. It is noted here that the stylet may include one ofa variety of configurations in addition to what is explicitly describedherein. In one embodiment, the stylet can attach directly to the consoleinstead of an indirect attachment via the TLS sensor. In anotherembodiment, the structure of the stylet 130 that enables its TLS andECG-related functionalities can be integrated into the catheterstructure itself. For instance, the magnetic assembly and/or ECG sensorassembly can, in one embodiment, be incorporated into the wall of thecatheter.

FIGS. 13A-15 describe various details relating to the passage of ECGsignal data from the stylet tether 134 to the TLS sensor 50 positionedon the patient's chest, according the present embodiment. In particular,this embodiment is concerned with passage of ECG signal data from asterile field surrounding the catheter 72 and insertion site 73, whichincludes the stylet 130 and tether 134, and a non-sterile field, such asthe patient's chest on which the TLS sensor is positioned. Such passageshould not disrupt the sterile field so that the sterility thereof iscompromised. A sterile drape that is positioned over the patient 70during the catheter insertion procedure defines the majority of thesterile field: areas above the drape are sterile, while areas below(excluding the insertion site and immediately surrounding region) arenon-sterile. As will be seen, the discussion below includes at least afirst communication node associated with the stylet 130, and a secondcommunication node associated with the TLS sensor 50 that operablyconnect with one another to enable ECG signal data transfertherebetween.

One embodiment addressing the passage of ECG signal data from thesterile field to the non-sterile field without compromising thesterility of the former is depicted in FIGS. 13A-15, which depict a“through-drape” implementation also referred to as a “shark fin”implementation. In particular, FIG. 14A shows the TLS sensor 50 asdescribed above for placement on the chest of the patient during acatheter insertion procedure. The TLS sensor 50 includes on a topsurface thereof a connector base 152 defining a channel 152A in whichare disposed three electrical base contacts 154. A fin connector 156,also shown in FIGS. 13A-13D, is sized to be slidingly received by thechannel 152A of the connector base 152, as shown in FIG. 14B and 15. TwoECG lead/electrode pairs 158 extend from the fin connector 156 forplacement on the shoulder and torso or other suitable external locationson the patient body. The drape-piercing tether connector 132 isconfigured to slidingly mate with a portion of the fin connector 156, aswill be described further below, to complete a conductive pathway fromthe stylet 120, through the sterile field to the TLS sensor 50.

FIGS. 13A-13D show further aspects of the fin connector 156. Inparticular, the fin connector 156 defines a lower barrel portion 160that is sized to be received in the channel 152A of the connector base152 (FIGS. 14B, 15). A hole 162 surrounded by a centering cone 164 isincluded on a back end of an upper barrel portion 166. The upper barrelportion 166 is sized to receive the tether connector 132 of the stylet130 (FIGS. 14C, 15) such that a pin contact 170 extending into a channel172 of the tether connector 132 (FIG. 15) is guided by the centeringhole until it seats within the hole 162 of the fin connector 156, thusinterconnecting the tether connector with the fin connector. Anengagement feature, such as the engagement feature 169 shown in FIGS.13C and 13D, can be included on the fin connector 156 to engage with acorresponding feature on the tether connector 132 to assist withmaintaining a mating between the two components.

FIG. 13D shows that the fin connector 156 includes a plurality ofelectrical contacts 168. In the present embodiment, three contacts 168are included: the two forward-most contact each electrically connectingwith a terminal end of one of the ECG leads 158, and the rear contactextending into axial proximity of the hole 162 so as to electricallyconnect with the pin contact 170 of the tether connector 132 when thelatter is mated with the fin connector 156 (FIG. 15). A bottom portionof each contact 168 of the fin connector 156 is positioned toelectrically connect with a corresponding one of the base contacts 154of the TLS sensor connector base 152.

FIG. 14B shows a first connection stage, wherein the fin connector 156is removably mated with the TLS sensor connector base 152 by the slidingengagement of the lower barrel portion 160 of the fin connector with theconnector base channel 152A. This engagement electrically connects theconnector base contacts 154 with the corresponding fin contacts 168.

FIG. 14C shows a second connection stage, wherein the tether connector132 is removably mated with the fin connector 156 by the slidingengagement of the tether connector channel 172 with the upper barrelportion 166 of the fin connector. This engagement electrically connectsthe tether connector pin contact 170 with the back contact 168 of thefin connector 156, as best seen in FIG. 15. In the present embodiment,the horizontal sliding movement of the tether connector 132 with respectto the fin connector 156 is in the same engagement direction as when thefin connector is slidably mated to the sensor connector base channel152A (FIG. 14B). In one embodiment, one or both of the stylet 130/tetherconnector 132 and the fin connector 156 are disposable. Also, the tetherconnector in one embodiment can be mated to the fin connector after thefin connector has been mated to the TLS sensor, while in anotherembodiment the tether connector can be first mated to the fin connectorthrough the surgical drape before the fin connector is mated to the TLSsensor.

In the connection scheme shown in FIG. 14C, the stylet 130 is operablyconnected to the TLS sensor 50 via the tether connector 132, thusenabling the ECG sensor assembly of the stylet to communicate ECGsignals to the TLS sensor. In addition, the ECG lead/electrode pairs 158are operably connected to the TLS sensor 50. In one embodiment,therefore, the tether connector 132 is referred to as a firstcommunication node for the stylet 130, while the fin connector 156 isreferred to as a second communication node for the TLS sensor 50.

Note that various other connective schemes and structures can beemployed to establish operable communication between the stylet and theTLS sensor. For instance, the tether connector can use a slicing contactinstead of a pin contact to pierce the drape. Or, the fin connector canbe integrally formed with the TLS sensor. These and other configurationsare therefore embraced within the scope of embodiments of the presentdisclosure.

As seen in FIG. 15, a sterile drape 174 used during catheter placementto establish a sterile field is interposed between the interconnectionof the tether connector 132 with the fin connector 156. As justdescribed, the tether connector 132 includes the pin contact 170 that isconfigured to pierce the drape 174 when the two components are mated.This piercing forms a small hole, or perforation 175, in the steriledrape 174 that is occupied by the pin contact 170, thus minimizing thesize of the drape perforation by the pin contact. Moreover, the fitbetween the tether connector 132 and the fin connector 156 is such thatthe perforation in sterile drape made by piercing of the pin contact 170is enclosed by the tether connector channel 172, thus preserving thesterility of the drape and preventing a breach in the drape that couldcompromise the sterile field established thereby. The tether connectorchannel 172 is configured so as to fold the sterile drape 174 down priorto piercing by the pin contact 170 such that the pin contact does notpierce the drape until it is disposed proximate the hole 162 of the finconnector 156. It is noted here that the tether connector 132 and finconnector 156 are configured so as to facilitate alignment therebetweenblindly through the opaque sterile drape 174, i.e., via palpation absentvisualization by the clinician of both components.

Note further that the fin contacts 168 of the fin connector 156 as shownin FIG. 15 are configured to mate with the sensor base contacts 154 insuch a way as to assist in retaining the fin connector in engagementwith the sensor base channel 152A. This in turn reduces the need foradditional apparatus to secure the fin connector 156 to the TLS sensor50.

FIG. 16 shows a typical ECG waveform 176, including a P-wave and a QRScomplex. Generally, the amplitude of the P-wave varies as a function ofdistance of the ECG sensor assembly from the SA node, which produces thewaveform 176. A clinician can use this relationship in determining whenthe catheter tip is properly positioned proximate the heart. Forinstance, in one implementation the catheter tip is desirably placedwithin the lower one-third (⅓rd) of the superior vena cava, as has beendiscussed. The ECG data detected by the ECG sensor assembly of thestylet 130 is used to reproduce waveforms such as the waveform 176, fordepiction on the display 30 of the system 10 during ECG mode.

Reference is now made to FIG. 17 in describing display aspects of ECGsignal data on the display 30 when the system 10 is in ECG mode, thethird modality described further above, according to one embodiment. Thescreenshot 178 of the display 30 includes elements of the TLS modality,including a representative image 120 of the TLS sensor 50, and can theicon 114 corresponding to the position of the distal end of the stylet130 during transit through the patient vasculature. The screenshot 178further includes a window 180 in which the current ECG waveform capturedby the ECG sensor assembly of the stylet 130 and processed by the system10 is displayed. The window 180 is continually refreshed as newwaveforms are detected.

Window 182 includes a successive depiction of the most recent detectedECG waveforms, and includes a refresh bar 182A, which moves laterally torefresh the waveforms as they are detected. Window 184A is used todisplay a baseline ECG waveform, captured before the ECG sensor assemblyis brought into proximity with the SA node, for comparison purposes toassist the clinician in determining when the desired catheter tiplocation has been achieved. Windows 184B and 184C can be filed byuser-selected detected ECG waveforms when the user pushes apredetermined button on the probe 40 or the console button interface 32.The waveforms in the windows 184B and 184C remain until overwritten bynew waveforms as a result of user selection via button pushes or otherinput. As in previous modes, the depth scale 124, status/action indicia126, and button icons 128 are included on the display 30. An integrityindicator 186 is also included on the display 30 to give an indicationof whether the ECG lead/electrode pairs 158 are operably connected tothe TLS sensor 50.

As seen above, therefore, the display 30 depicts in one embodimentelements of both the TLS and ECG modalities simultaneously on a singlescreen, thus offering the clinician ample data to assist in placing thecatheter distal tip in a desired position. Note further that in oneembodiment a printout of the screenshot or selected ECG or TLS data canbe saved, printed, or otherwise preserved by the system 10 to enabledocumentation of proper catheter placement.

Although the embodiments described herein relate to a particularconfiguration of a catheter, such as a PICC or CVC, such embodiments aremerely exemplary. Accordingly, the principles of the present inventioncan be extended to catheters of many different configurations anddesigns.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

1. An integrated catheter placement system for placing a catheter in avasculature of a patient, comprising: a system console; a tip locationsensor configured for temporary placement on a portion of a body of thepatient, the tip location sensor configured for sensing a magnetic fieldof a stylet disposed in a lumen of the catheter when a distal portion ofthe catheter is disposed in the vasculature, the tip location sensorbeing operably connected to the system console; and an ultrasound probefor ultrasonically imaging an internal portion of the patient prior tointroduction of the catheter into the vasculature, the ultrasound probeoperably connected to the console, the ultrasound probe including userinput controls for controlling use of the ultrasound probe in anultrasound mode and use of the tip location sensor in a tip locationmode.
 2. The system as defined in claim 1, further comprising a displayfor depicting information relating to the ultrasonic mode and the tiplocation mode.
 3. The system as defined in claim 2, wherein the displayis integrated into the console, and wherein the console includes atleast one control processor.
 4. The system as defined in claim 1,wherein the user input controls are buttons included on the ultrasoundprobe.
 5. The system as defined in claim 1, wherein the user inputcontrols of the ultrasound probe enable toggling of the display betweendepiction of information relating to the ultrasonic mode and informationrelating to the tip location mode.
 6. The system as defined in claim 5,wherein the console includes a button interface that enables thetoggling of the display.
 7. The system as defined in claim 1, whereinthe magnetic field of the stylet is provided by at least one magneticelement included proximate a distal end of the stylet, the distal end ofthe stylet being substantially co-terminal with a distal end of thecatheter.
 8. The system as defined in claim 1, wherein the stylet isremovable from the lumen of the catheter after the catheter placement iscomplete.
 9. The system as defined in claim 1, wherein the probe islocated within a sterile field during use of the system, and wherein theprobe enables use of the system by a clinician without requiring theclinician to penetrate out of the sterile field.
 10. The system asdefined in claim 1, wherein the magnetic field of the stylet is producedby a component including one of the following: a permanent magnet, anelectromagnet, and any combination of the foregoing.
 11. The system asdefined in claim 1, further comprising an ECG tip confirmation componentfor determining proximity of a distal tip of the catheter to asino-atrial node of a heart of the patient, the ECG tip confirmationcomponent including: an ECG sensor assembly included on the stylet fordetecting electrical activity of the sino-atrial node; and a referenceelectrode and a ground electrode for placement on an external portion ofthe patient, the ECG sensor assembly, reference electrode, and groundelectrode being operably connected to the system console via the tiplocation sensor.
 12. An integrated catheter placement system for placinga catheter in a vasculature of a patient, comprising: a consoleincluding a display; an ultrasound probe operably connected to theconsole for ultrasonically imaging a portion of the vasculature fordepiction on the display; a magnetic assembly associated with thecatheter; and a tip location sensor operably connected to the consolefor depiction on the display of information relating to detection by thetip location sensor of a magnetic field of the magnetic assembly so asto determine a position of the catheter with respect to the tip locationsensor during advancement of the catheter in the vasculature.
 13. Thesystem as defined in claim 12, wherein the tip location sensor ispositionable on a chest of the patient during catheter placement, andwherein the magnetic assembly is included with a stylet that isremovably inserted in a lumen of the catheter, the stylet including atleast one magnetic element.
 14. The system as defined in claim 13,wherein the at least one magnetic element includes a plurality offerromagnetic elements.
 15. An integrated catheter placement system,comprising: a system console; a tip location sensor operably connectedto the system console and positionable onto a body of a patient, the tiplocation sensor sensing a magnetic field of a stylet disposed in a lumenof a catheter when a distal portion of the catheter is inserted into thebody of the patient; an ultrasound probe operably connected to thesystem console, the ultrasound probe ultrasonically imaging an internalportion of the patient prior to insertion of the catheter into the bodyof the patient, the ultrasound probe including user input controls forcontrolling use of the ultrasound probe in an ultrasound mode and use ofthe tip location sensor in a tip location mode; and an ECG tipconfirmation component operably connected to the system console via thetip location sensor, the ECG tip confirmation component determiningproximity of a distal tip of the catheter to a sino-atrial node of aheart of the patient, the ECG tip confirmation component including anECG sensor assembly coupled to the stylet, and a reference electrode anda ground electrode placed onto the body of the patient.
 16. A method forplacing a catheter within a vasculature of a patient, the methodcomprising: ultrasonically imaging a portion of the vasculature fordepiction on a display of a console; introducing the catheter into thevasculature of the patient, the catheter including a magnetic assemblyassociated therewith; and detecting a magnetic field of the magneticassembly when the catheter is within the vasculature of the patient fordepiction on the display of the console.
 17. The method for placing asdefined in claim 16, further comprising, controlling the stages ofultrasonically imaging and detecting the magnetic field without reachingout of a sterile field of the patient.
 18. The method for placing asdefined in claim 17, further comprising detecting an ECG signal of aheart node of the patient by an ECG sensor assembly associated with thecatheter when the catheter is within the vasculature of the patient fordepiction on the display of the console.
 19. The method for placing asdefined in claim 18, further comprising controlling the stage ofdetecting the ECG signal without reaching out of a sterile field of thepatient.
 20. The method for placing as defined in claim 19, furthercomprising selectively displaying information relating to the stages ofultrasonically imaging, detecting the magnetic field, and detecting theECG signal by user input via an ultrasonic probe operably connected tothe console.